BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPACT ACETABULAR SHELL Ø50 MULTI-HOLE

    MDR report key: 6731724 · Received July 21, 2017

    Report

    Report Number
    3005180920-2017-00396
    Event Type
    Malfunction
    Date Received
    July 21, 2017
    Date of Event
    June 22, 2017
    Report Date
    October 6, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810770
    PMA / PMN Number
    K132879
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 21 JULY 2017. LOT 165282: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21 NOVEMBER 2016. EXPIRATION DATE: 2021-11-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. MPACT CUP IMPACTOR, CODE 01.32.10.0183, LOT. 1654383 (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17 FEBRUARY 2017. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, THIS IS THE SECOND SIMILAR EVENT REPORTED ON ITEMS OF THE SAME LOT.

    Additional Manufacturer Narrative · 1

    THE CUP WAS REPORTED AS AVAILABLE FOR INVESTIGATION IN THE INITIAL REPORT, HOWEVER THE PIECE WAS NEVER RECEIVED BY MEDACTA INTERNATIONAL SA. THE COMPLAINT HAS BEEN CLOSED WITHOUT VISUAL INSPECTION OF THE ITEM. IN CASE OF ITEM RETURN, A FOLLOW-UP REPORT WILL BE SENT TO FDA. ON 29 SEPTEMBER 2017 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INITIAL REPORT. ON 06 OCTOBER 2017 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.

    Description of Event or Problem · 1

    DURING SURGERY THE CUP IMPACTOR WOULD NOT DISENGAGE FROM THE CUP. THE SURGEON REMOVED THE IMPACTOR AND CUP. AFTER 10 MINUTES, THE SURGEON WAS ABLE TO DISENGAGE THE CUP FROM THE IMPACTOR. THE SURGEON MANUALLY IMPACTED THE CUP WITH A BALL IMPACTOR. THE SURGERY WAS COMPLETED SUCCESSFULLY. INSTRUMENTATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514233 MPACT ACETABULAR SHELL Ø50 MULTI-HOLE CEMENTLESS ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 165282 07630030810770

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other